The Opportunity

Looking for RA Specialists with at least 2 years experience in commercial or clinical regulatory affairs, in classifications ranging across pharmaceuticals: NCEs, NDAs, Biologics, Biosimilars, etc.

Professionals with relevant experience in handling CMC product life cycle management in regulatory affairs are welcome to apply, to handle product registration and variations, CMC compliance, labeling and change management, CPP/GMP management, license maintenance, import/export regulations etc.

What You Will Learn

Job Description

Provide full range of services related to regulatory affairs with a thorough understanding of regulations and industry practices in Singapore and other regional countries and beyond as required. Cover end to end all aspects from product registration to provide regulatory support and intelligence, review for CMC compliance, communicate effectively with health authorities for submission of dossiers and following up on post-approval commitments etc.

Senior RA Specialists may be involved in CMC and post-approval strategies, be involved in submission planning and forecasting, work with stakeholders to meet regulatory timelines, ensure systems and database are updated for consistency and completeness. Knowledge in quality systems, processes, audit and inspections; and experienced in people management, able to manage regulatory issues to deliver quality work on time, would be advantageous.

Requirements

• Bachelors degree or higher in Science, Bio/Med Technology, Engineering or Pharmacy may apply
• Candidate should have minimum 1 - 2 years of experience doing regulatory affairs, product registration and submissions to the regulatory authorities.
• Be a problem solver, self-driven, able to work independently and as a team in dynamic environments, able to manage projects to completion within allocated timeline.
• Be resourceful and able to seek answers to challenging questions regarding the Asian Regulatory environment. Technical writing / marketing ability will be a bonus.